Memory LossPhase 2NCT00051402
Phytoestrogens and Memory Decline in Menopause
A Phase 2 study testing Isoflavones in people with Memory Loss and Postmenopause, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether soy-derived phytoestrogens taken as dietary supplements improve memory function in postmenopausal women who have experienced early memory decline. Read more about this study
- Who is it for?
- Ages 62 years and older, women only
- Conditions the study is for
- Memory Loss, Postmenopause
- What is being tested?
- Isoflavones
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 62 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Mild memory or cognitive decline that does not meet the criteria for probable dementia
- Exlcusion Criteria
- Hormone replacement therapy within 2 months prior to study entry
- Psychiatric medications within 30 days prior to study entry
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267-0559
About this study
Official title: Phytoestrogens and Cognition in Menopause
The purpose of this study is to investigate whether soy-derived phytoestrogens taken as dietary supplements improve memory function in postmenopausal women who have experienced early memory decline.
Read the detailed description
Accumulating data has indicated that estrogens mediate enhancing effects on cognition and mood and may play a prophylactic role against age- and disease-related cognitive-cerebral decline. Phytoestrogens are plant-derived substances that have demonstrated estrogenic activity, but there is little prospective research regarding their effects on mental function. Mental health practitioners generally do not prescribe phytoestrogens. However, many women experiencing peri- and post-menopausal symptoms use marketed phytoestrogens under the perception of general health benefits, including presumably enhanced mental function. The purpose of this study is to develop preliminary data regarding the efficacy of isoflavone phytoestrogens in improving cognitive function in late middle-aged and elderly postmenopausal women with symptoms of memory impairment.
Participants in this study will be randomized to receive either isoflavone supplementation or placebo. The study will last for 16 weeks, during which participants will take the supplement pill or placebo three times a day. Participants will be assessed at study entry and at Week 16 for changes in basal cortisol levels, mood, and neuropsychological measures of executive function ability and episodic memory.
- Conditions
- Memory Loss, Postmenopause
- Being tested
- Isoflavones
- Keywords
- Postmenopausal, Memory Loss, Cognition, Phytoestrogens
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoflavonesDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2003 (estimated)
- Study startDec 2002
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert Krikorian, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051402
- Sponsor's protocol ID
- R21AT000567-01A1
- Status last verified
- Oct 2007
- First submitted
- 9 Jan 2003
- Last updated
- 26 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phytoestrogens and Cognition in Menopause
- ClinicalTrials.gov ID
- NCT00051402
- Acronym / sponsor ID
- R21AT000567-01A1
- Conditions
- Memory Loss, Postmenopause
- Keywords
- Postmenopausal, Memory Loss, Cognition, Phytoestrogens
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Dec 2002
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether soy-derived phytoestrogens taken as dietary supplements improve memory function in postmenopausal women who have experienced early memory decline.
Detailed description
Accumulating data has indicated that estrogens mediate enhancing effects on cognition and mood and may play a prophylactic role against age- and disease-related cognitive-cerebral decline. Phytoestrogens are plant-derived substances that have demonstrated estrogenic activity, but there is little prospective research regarding their effects on mental function. Mental health practitioners generally do not prescribe phytoestrogens. However, many women experiencing peri- and post-menopausal symptoms use marketed phytoestrogens under the perception of general health benefits, including presumably enhanced mental function. The purpose of this study is to develop preliminary data regarding the efficacy of isoflavone phytoestrogens in improving cognitive function in late middle-aged and elderly postmenopausal women with symptoms of memory impairment.
Participants in this study will be randomized to receive either isoflavone supplementation or placebo. The study will last for 16 weeks, during which participants will take the supplement pill or placebo three times a day. Participants will be assessed at study entry and at Week 16 for changes in basal cortisol levels, mood, and neuropsychological measures of executive function ability and episodic memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 62 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women
- Mild memory or cognitive decline that does not meet the criteria for probable dementia
- Exlcusion Criteria
- Hormone replacement therapy within 2 months prior to study entry
- Psychiatric medications within 30 days prior to study entry
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoflavones | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2007.
Related trials for Memory Loss
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
RecruitingEarly Phase 1
Pharmacological Modulation of Brain Oscillations in Memory Processing
Epilepsy, Seizures
Recruiting
NON-INVASIVE BRAIN STIMULATION FOR MEMORY LOSS IN EARLY ALZHEIMER'S DISEASE
Alzheimer s Disease, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Krikorian, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isoflavones in people with Memory Loss and Postmenopause, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2007.